What they wrote:
PROPOSED DRAFT GUIDELINES FOR VITAMIN AND MINERAL
SUPPLEMENTS 2
PREAMBLE
Most people who have access to a balanced diet should usually obtain all
the nutrients they require from their normal diet. People should
therefore be encouraged to select such a balanced diet from food before
considering any dietary supplement.
Translation:
Although we have set ourselves up as an international body to
regulate the
manufacture and sale of vitamin and mineral supplements, we have no first-hand experience and no actual knowledge about
the proper use of supplements, so we want to state at the get-go that we
don't believe in them. You, the consumers of the
world, need to be protected from yourselves, and from spending
one thin dime on that garbage, all of which is already in your food, no
matter how much you eat or what you eat, as our expert medical shills
have told you countless times. However, when we are able to pass
these guidelines, then your doctors will write you a prescription for
supplements and those supplements will be all good. (But
I'm getting ahead of myself...)
What they wrote:
1. SCOPE
These guidelines apply to vitamin and mineral supplements intended for
use in supplementing the daily diet with vitamins and/or minerals. It is
left to national regulations to decide whether vitamin and mineral
supplements are drugs or foods. These Guidelines do not apply in those
jurisdictions where products defined in 2.1 are regulated as drugs.
2. DEFINITIONS
2.1 Vitamin and mineral supplements for the purpose of these guidelines
derive their nutritional relevance primarily from the minerals and/or
vitamins they contain. They can be marketed in capsules, tablets,
powders, liquids etc. [They serve to supplement the daily diet with
these nutrients in cases when the intake from food is insufficient or
where the consumers consider their diet requires
supplementation.]
2.2 For the purpose of the Guidelines, vitamin and mineral supplements
are considered as foods (as defined in the Procedural Manual of the
Codex Alimentarius, 9th edition, 1995, p.59), if not otherwise stated in
national regulations.
2.3 Vitamin and mineral supplements can serve special nutritional
purposes, if their composition and contents of minerals and vitamins
corresponds to particular dietary requirements that result from certain
physical or physiological conditions and they are marketed for that
particular purpose.
Translation:
Scope and Definition
These guidelines apply to vitamin and mineral supplements in countries
where you can, as of right now, freely buy them in Health Food stores
and consume them as you see fit, countries such as the United
States. They do not apply in countries where you first need to go
to a doctor, obtain a prescription, and then go to a licensed pharmacist
and pay 5 to 20 times as much for them; in other words, these don't
apply in countries where supplements are already safely classified as
drugs.
We're talking about all those capsules, tablets,
powders, liquids, etc. that silly consumers insist on taking, in those
countries where such concoctions are not yet classified as drugs.
They may be marketed for special nutritional purposes, until such time
as we are able
to reclassify all such purposes as disease states and therefore the
supplements as drugs.
What they wrote:
3. COMPOSITION
3.1 SELECTION OF VITAMINS AND MINERALS
3.1.1 Vitamin and mineral supplements shall contain vitamins/provitamins
and only minerals in conjunction with the relevant Codex standards whose
indispensability for human beings has been proven by scientific data [up
to a level considered safe as determined by risk analysis] [and which
are
covered by recommendations for the daily intake or estimated values for
safe and adequate intake established by recognized scientific
authorities].
3.1.2 The selection of admissible nutrient compounds may be based on
nutrient criteria of the FAO/WHO or Pharmacopoeias and national
legislation.
3.1.3 The use of supplements of individual vitamins and minerals can be
[limited] for reasons of health protection and consumer safety, taking
into account regional or national peculiarities concerning the supply
situation of the population.
3.1.4 Vitamin and mineral supplements may contain all vitamins and
minerals that comply with the criteria in 3.1.1, a single nutrient or an
appropriate combination of nutrients. [The suitability of a single
nutrient or a combination of several nutrients in a vitamin and mineral
supplement for the special nutritional purpose for which it is marketed
should be proven by scientific data.]
3.2 CONTENTS OF VITAMINS AND MINERALS
3.2.1 The minimum level of each nutrient contained in a vitamin and
mineral supplement should be [15%] of the recommended daily intake or
the estimated safe and adequate daily intake.
3.2.2 [The maximum level of each nutrient contained in a vitamin and
mineral supplement should not exceed [100%] of the recommended daily
intake or the estimated safe and adequate intake per daily dose.]
[Alternatively for 3.2.1 and 3.2.2, vitamin and mineral supplements
should contain nutritionally
relevant nutrient levels. The daily dose shall not exceed the
physiological quantity. These dosages shall remain below the dose range
that produces pharmacological effects.] or [3.2.1 Supplements may
contain vitamins and minerals up to a level that is considered safe on
the basis of risk assessment considerations, as determined by
appropriate risk assessment methodology,
taking into account all sources of nutrients in the diet.]
3.2.3 For vitamins and minerals with a narrow safety margin between the
recommended daily intake and the adverse effect level, difference
maximum limits for the daily dose may be established at the national
level.
Translation:
Composition
Vitamin and mineral supplements shall contain only the substances we
officially allow, and one way or the other, only at levels established
by "recognized scientific
authorities." Since we'll be doing the recognizing, that
pretty much means levels established by ... us.
On the other hand, we can limit the use of vitamins
and minerals at any time in the name of "health protection and
consumer safety."
If you decide to market a vitamin or mineral
supplement anyway - we hope you're getting the idea not to - you must
not say anything about it's use that can't be proven by information only
we can authorize. Get it?
As to how much of any nutrient can be in a product,
we will come up with some way of saying that no supplement can contain
any amount of a nutrient that might possibly give a result exceeding
that of staving off stark deficiency disease.
What they wrote:
4. FOOD ADDITIVES
The additives authorized by the Joint FAO/WHO Expert Committee on Food
Additives (JECFA) are permissible, provided they are necessary for
technological reasons and do not exceed the equivalent of their
acceptable daily intakes (ADI).
Translation:
Food Additives
Feel free to throw these in, but only if they don't confer any health
benefits. They may only help in the production and packaging and
marketing of the pills. You may only use the additives we ourselves have
authorized already.
What they wrote:
5. CONTAMINANTS
The product shall be prepared with special care under good manufacturing
practices and shall be free of pesticides and other contaminants to the
maximum extent possible.
Translation:
Contaminants
Contaminants are not good, but since 90% of the non-governmental members
of Codex represent the international corporations that make these
chemical contaminants, we propose no specific "risk" standards for these;
just reduce them "to the max".
What they wrote:
6. HYGIENE
6.1 To the extent possible in good manufacturing practice, the product
shall be free from objectionable matter.
6.2 When tested by appropriate methods of sampling and examination, the
product:
(a) shall be free from pathogenic microorganisms;
(b) shall not contain any substances originating from microorganisms in
amounts which may represent a hazard to health; and
(c) shall not contain any other poisonous or deleterious substances in
amounts which may represent a hazard to health.
Translation:
Hygiene
Keep it clean, especially from those nasty bugs. As to hazardous
chemicals, we name no names, but definitely keep them below levels that
might trigger a real public health scare, or you'll blow the
whole game.
What they wrote:
7. PACKAGING
7.1 The product shall be packed in containers which will safeguard the
hygienic and other qualities of the food.
7.2 The containers, including packaging material, shall be made only of
substances which are safe and suitable for their intended use. Where the
Codex Alimentarius Commission has established a standard for any such
substance used as packaging material, that standard shall apply.
7.3 Vitamin and mineral supplements should be distributed in
child-resistant packagings, if necessary.
Translation:
Packaging
Use the Codex-Approved packaging standards. Even though the Health
Food Industry has long ago adopted child-resistant packaging for iron
supplements (and before drugstore supplements did), we remind you anyway.
What they wrote:
8. LABELING
8.1 Dietary supplements are labeled according to the Codex Standard for
the Labeling of Prepackaged Foods (Codex-Stan 1-1985) as well as
according to the General Guidelines on Claims (CAC/GL 1-1979), the
Guidelines on Nutrition Labeling (CAC/GL 2-1985).
8.2 The name of the product shall be "vitamin and mineral
supplement" or "dietary mineral/vitamin preparation to
supplement the diet with ...", with an indication of the nutrients
contained therein or " vitamin and mineral supplement in cases of
...", with an indication of the special nutritional
purposes for products that meet the criteria of 2.2 and 3.1.4.
8.3 The label must indicate the biologically active part of all vitamins
and minerals in units of weight per product unit and in the case of
liquids per recommended dose unit. Additionally, the percentage of the
[recommended daily intake] of the vitamin or mineral that is covered by
the consumption of the recommended daily dose of the product must be
indicated.
8.4 The label must indicate the recommendations on how to take the
product (quantity, frequency,
special conditions).
8.5 The label must contain a warning statement [if the product contains
a significant amount of a
nutrient with respect to the toxicity level.]
Translation:
Labeling
No fancy names! Who do you think you are, drug companies?
All products shall be "vitamin and mineral supplement" (it
really does say this!) Include recommendations of how to take this product (even
though you must not actually say on the label what benefit the consumer
might gain by taking it), and always use warning statements about the
little-known toxicity levels of nutrients, which we will soon
"prove".
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